US2020163785A1PendingUtilityA1

Disintegrable gastrointestinal anchoring systems and methods of use thereof

43
Assignee: GI DYNAMICS INCPriority: Jul 21, 2017Filed: Jul 23, 2018Published: May 28, 2020
Est. expiryJul 21, 2037(~11 yrs left)· nominal 20-yr term from priority
Inventors:Scott SchorerChris Thompson
A61F 2/04C08L 2201/06A61F 5/0076C08L 67/04B29K 2995/0006A61B 17/0401B29K 2067/00A61B 2017/0464A61B 2017/0437A61B 2017/0414A61B 2017/00818A61B 2017/00004
43
PatentIndex Score
0
Cited by
0
References
0
Claims

Abstract

The invention features a gastrointestinal anchoring system for securing a gastrointestinal device within the gastrointestinal tract of a patient. Further provided are methods of using the anchoring system to secure a gastrointestinal device within the gastrointestinal tract of a patient and methods of treatment using the anchoring system of the invention to secure a gastrointestinal device of the invention to a luminal wall within a patient's gastrointestinal tract.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . An anchoring system for securing a gastrointestinal device to a gastrointestinal tract of a patient, the anchoring system comprising a plurality of disintegrable anchors releasably connected by a disintegrable tether, wherein the gastrointestinal device is held in place by the disintegrable anchors when the tether is intact, and whereupon disintegration of the tether, the gastrointestinal device is releasable from the disintegrable anchors. 
     
     
         2 . The anchoring system of  claim 1 , wherein the disintegration of the tether is configured to occur prior to the disintegration of the plurality of disintegrable anchors. 
     
     
         3 . The anchoring system of  claim 1 , wherein the disintegration of the plurality of disintegrable anchors is configured to occur prior to the disintegration of the tether. 
     
     
         4 . The anchoring system of any one of  claims 1 - 3 , wherein the disintegrable tether comprises the same material as the disintegrable anchors. 
     
     
         5 . The anchoring system of any one of  claims 1 - 4 , wherein the disintegrable tether comprises a different material than the disintegrable anchors. 
     
     
         6 . The anchoring system of any one of  claims 1 - 5 , wherein the disintegrable tether has at least one cross-sectional dimension that is less than 50% of that of the smallest cross-sectional width of the disintegrable anchor. 
     
     
         7 . The anchoring system of any one of  claims 1 - 6 , wherein the disintegrable tether has a circular cross-section. 
     
     
         8 . The anchoring system of any one of  claims 1 - 6 , wherein the disintegrable tether has a non-circular cross-section. 
     
     
         9 . The anchoring system of  claim 8 , wherein the tether has a non-circular cross-section such that the cross-sectional width is at least 100% greater than the cross-sectional height. 
     
     
         10 . The anchoring system of any one of  claims 1 - 9 , wherein each of the disintegrable anchors comprises a tissue penetrating projection and a protruding portion. 
     
     
         11 . The anchoring system of  claim 10 , wherein the longitudinal length of the tissue penetrating projection is about 1 mm to about 20 mm. 
     
     
         12 . The anchoring system of  claim 10  or  11 , wherein the tissue penetrating projection comprises one or more tissue retention elements. 
     
     
         13 . The anchoring system of  claim 12 , wherein the one or more tissue retention elements comprise hooks, prongs, or ridges. 
     
     
         14 . The anchoring system of claims any one of  claims 10 - 13 , wherein the longitudinal length of the protruding portion is at least 5% less than the longitudinal length of the tissue penetrating projection. 
     
     
         15 . The anchoring system of any one of  claims 10 - 14 , wherein the protruding portion comprises an eyelet through which the disintegrable tether passes. 
     
     
         16 . The anchoring system of  claim 15 , wherein the eyelet of the protruding portion is circular. 
     
     
         17 . The anchoring system of  claim 15 , wherein the eyelet of the protruding portion is non-circular. 
     
     
         18 . The anchoring system of any of  claims 15 - 17 , wherein the width of the opening of the eyelet is at least 10% greater than the maximum width of the tether. 
     
     
         19 . The anchoring system of  claims 10 - 18 , wherein the tissue penetrating projection and the protruding portion comprise the same material. 
     
     
         20 . The anchoring system of  claims 1 - 19 , wherein the disintegrable anchor comprises a degradable material selected from the group consisting of poly(lactic acid) (PLA), poly(glycolic acid) (PGA), poly (L-lactic acid) (PLLA), poly-DL-lactide (PDLLA), diolamine, trimethylene carbonate, caprolactone, and copolymers thereof. 
     
     
         21 . The anchoring system of  claim 20 , wherein disintegrable anchor comprises PLLA. 
     
     
         22 . The anchoring system of any one of  claims 10 - 18 , wherein the tissue penetrating projection and the protruding portion are different materials. 
     
     
         23 . The anchoring system of  claim 18 , wherein the tissue penetrating projection comprises a degradable material selected from the group consisting of PLA, PGA, PDLLA, diolamine, trimethylene carbonate, caprolactone, and copolymers thereof. 
     
     
         24 . The anchoring system of  claim 20 , wherein tissue penetrating projection comprises PLA. 
     
     
         25 . The anchoring system of any one of  claims 10 - 18 , wherein the protruding portion comprises a non-degradable material. 
     
     
         26 . The anchoring system of  claim 25 , wherein the protruding portion comprises a non-degradable material selected from the group consisting of stainless steel, CoCr alloys, nitinol, tantalum, polyethylene, polyether ether ketone (PEEK), and ceramic. 
     
     
         27 . The anchoring system of  claim 26 , wherein protruding portion comprises PEEK. 
     
     
         28 . The anchoring system of  claims 1 - 9 , wherein the disintegrable tether is a loop. 
     
     
         29 . The anchoring system of  claims 1 - 9 , wherein the disintegrable tether is a suture. 
     
     
         30 . The anchoring system of  claim 1 - 9 , wherein the disintegrable tether comprises a break point and a non-degradable portion. 
     
     
         31 . The anchoring system of  claim 30 , wherein the break point is a degradable material selected from the group consisting of PLA, PGA, poly-LD-lactide (PLDLA), polydioxanone (PDO), dioxanone, trimethylene carbonate, caprolactone, and copolymers thereof. 
     
     
         32 . The anchoring system of  claim 30  or  31 , wherein the break point is PLDLA. 
     
     
         33 . The anchoring system of any one of  claims 29 - 32 , wherein the non-degradable portion comprises a material selected from the group consisting of stainless steel, CoCr alloys, nitinol, and tantalum. 
     
     
         34 . The anchoring system of  claim 33 , wherein the non-degradable portion comprises nitinol. 
     
     
         35 . The anchoring system of  claims 1 - 34 , wherein the disintegrable tether is a degradable material. 
     
     
         36 . The anchoring system of  claim 35 , wherein the degradable material is selected from the group consisting of PLA, PGA, PLGA, PDO, dioxanone, trimethylene carbonate, caprolactone, and copolymers thereof. 
     
     
         37 . The anchoring system of  claim 36 , wherein the degradable material is PDO. 
     
     
         38 . An anchoring system for securing a gastrointestinal device to a gastrointestinal tract of a patient, the anchoring system comprising a plurality of anchors releasably connected by a disintegrable tether, wherein the gastrointestinal device is held in place by the anchors when the disintegrable tether is intact, and whereupon disintegration of the tether, the gastrointestinal device is releasable from the anchors. 
     
     
         39 . The anchoring system of  claim 38 , wherein the disintegrable tether has at least one cross-sectional dimension that is less than 50% of that of the smallest cross-sectional width of the anchor. 
     
     
         40 . The anchoring system of  claim 38  or  39 , wherein the disintegrable tether has a circular cross-section. 
     
     
         41 . The anchoring system of  claim 38  or  39 , wherein the disintegrable tether has a non-circular cross-section. 
     
     
         42 . The anchoring system of  claim 40 , wherein the tether has a non-circular cross-section such that the cross-sectional width is at least 100% greater than the cross-sectional height. 
     
     
         43 . The anchoring system of any one of  claims 38 - 42 , wherein each of the anchors comprises a tissue penetrating projection and a protruding portion. 
     
     
         44 . The anchoring system of  claim 43 , wherein the longitudinal length of the tissue penetrating projection is about 1 mm to about 20 mm. 
     
     
         45 . The anchoring system of  claim 43  or  44 , wherein the tissue penetrating projection comprises one or more tissue retention elements. 
     
     
         46 . The anchoring system of  claim 45 , wherein the one or more tissue retention elements comprise hooks, prongs, or ridges. 
     
     
         47 . The anchoring system of claims any one of  claims 43 - 46 , wherein the longitudinal length of the protruding portion is at least 5% less than the longitudinal length of the tissue penetrating projection. 
     
     
         48 . The anchoring system of any one of  claims 43 - 47 , wherein the protruding portion comprises an eyelet through which the disintegrable tether passes. 
     
     
         49 . The anchoring system of  claim 48 , wherein the eyelet of the protruding portion is circular. 
     
     
         50 . The anchoring system of  claim 48 , wherein the eyelet of the protruding portion is non-circular. 
     
     
         51 . The anchoring system of any of  claims 48 - 50 , wherein the width of the opening of the eyelet is at least 10% greater than the maximum width of the tether. 
     
     
         52 . The anchoring system of any one of  claims 38 - 51 , wherein the anchor comprises a material selected from the group consisting of polyethylene terephthalate (PET), polyether ether ketone (PEEK), polytetrafluoroethylene (PTFE), polyoxymethylene, and ceramics. 
     
     
         53 . The anchoring system of any one of  claims 43 - 52 , wherein the tissue penetrating projection and the protruding portion are different materials. 
     
     
         54 . The anchoring system of  claim 53 , wherein the tissue penetrating projection comprises a material selected from the group consisting of PET, PEEK, polyoxymethylene, PTFE, and a ceramic. 
     
     
         55 . The anchoring system of  claim 54 , wherein tissue penetrating projection comprises PTFE. 
     
     
         56 . The anchoring system of  claim 53 , wherein the protruding portion comprises a material selected from the group consisting of stainless steel, CoCr alloys, nitinol, tantalum, polyethylene, polyether ether ketone (PEEK), PTFE, and ceramic. 
     
     
         57 . The anchoring system of  claim 56 , wherein protruding portion comprises PEEK. 
     
     
         58 . The anchoring system of  claims 38 - 42 , wherein the disintegrable tether is a loop. 
     
     
         59 . The anchoring system of  claims 38 - 42 , wherein the disintegrable tether is a suture. 
     
     
         60 . The anchoring system of  claim 38 - 42 , wherein the disintegrable tether comprises a break point and a non-degradable portion. 
     
     
         61 . The anchoring system of  claim 60 , wherein the break point is a degradable material selected from the group consisting of PLA, PLLA, PGA, poly-LD-lactide (PLDLA), polydioxanone (PDO), dioxanone, trimethylene carbonate, caprolactone, and copolymers thereof. 
     
     
         62 . The anchoring system of  claim 60  or  61 , wherein the break point is PLDLA. 
     
     
         63 . The anchoring system of any one of  claims 60 - 62 , wherein the non-degradable portion comprises a material selected from the group consisting of stainless steel, CoCr alloys, nitinol, and tantalum. 
     
     
         64 . The anchoring system of  claim 63 , wherein the non-degradable portion comprises nitinol. 
     
     
         65 . The anchoring system of  claims 1 - 64 , wherein the disintegrable tether is a degradable material. 
     
     
         66 . The anchoring system of  claim 65 , wherein the degradable material is selected from the group consisting of PLA, PGA, PLLA, PLGA, PDO, dioxanone, trimethylene carbonate, caprolactone, and copolymers thereof. 
     
     
         67 . The anchoring system of  claim 36 , wherein the degradable material is PDO. 
     
     
         68 . A gastrointestinal device comprising a conformable sleeve having a proximal end and a distal end, the gastrointestinal device configured to carry fluid from the proximal end to the distal end and, the gastrointestinal device further comprising a flange positioned at the proximal end of the sleeve, the flange having a plurality of apertures circumscribing the sleeve. 
     
     
         69 . The gastrointestinal device of  claim 68 , wherein the apertures in the flange are holes, slits, or slots. 
     
     
         70 . The gastrointestinal device of  claim 68  or  69 , wherein the flange is directly connected to the proximal end of the sleeve. 
     
     
         71 . The gastrointestinal device of any one of  claims 68 - 70 , wherein the flange and sleeve are made from a polymeric liner. 
     
     
         72 . The gastrointestinal device of  claim 71 , wherein the polymeric liner is selected from the group consisting of polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxy (PFA), ethylene tetrafluoroethylene (EFTE), and polyvinylidene fluoride (PVDF). 
     
     
         73 . The gastrointestinal device of  claim 72 , wherein the polymeric liner is PTFE. 
     
     
         74 . The gastrointestinal device of any one of  claims 68 - 73  wherein the flange is circular. 
     
     
         75 . The gastrointestinal device of any one of  claims 68 - 73 , wherein the flange is non-circular. 
     
     
         76 . The gastrointestinal device of any one of  claims 68 - 75 , wherein the outer diameter of the flange is at least 10% greater than the diameter of the sleeve. 
     
     
         77 . The gastrointestinal device of any one of  claims 68 - 76 , wherein the diameter of the sleeve is substantially constant along its length. 
     
     
         78 . The gastrointestinal device of any one of  claims 68 - 77 , wherein the sleeve is at least 30 cm in length. 
     
     
         79 . The gastrointestinal device of any one of  claims 68 - 78 , wherein the sleeve has a coefficient of friction of 0.3 or less. 
     
     
         80 . The gastrointestinal device of any one of  claims 68 - 79 , wherein the sleeve comprises an eversion-resistant element distal to the flange. 
     
     
         81 . The gastrointestinal device of any one of  claims 68 - 80 , further comprising the anchoring system of any one of  claims 1 - 67 . 
     
     
         82 . A kit comprising:
 (a) an anchoring system for attaching gastrointestinal device to a patient, the anchoring system comprising a plurality of disintegrable anchors that are releasably connected by a disintegrable tether, wherein the gastrointestinal device is held in place when the tether is intact, whereupon disintegration of the tether into one or more fragments, the gastrointestinal device is releasable from the anchors; and   (b) a gastrointestinal device comprising a conformable sleeve having a proximal end and a distal end configured to carry fluid from the proximal end to the distal end, the gastrointestinal device further comprising a flange positioned at the proximal end of the sleeve, the flange having a plurality of apertures circumscribing the sleeve.   
     
     
         83 . The kit of  claim 82 , wherein the anchoring system is the anchoring system of any one of  claims 1 - 67 . 
     
     
         84 . The kit of  claim 82  or  83 , wherein the gastrointestinal device is the gastrointestinal device of any one of  claims 68 - 81 . 
     
     
         85 . A kit comprising:
 (a) an anchoring system for attaching gastrointestinal device to a patient, the anchoring system comprising a plurality of anchors that are releasably connected by a disintegrable tether, wherein the gastrointestinal device is held in place when the tether is intact, whereupon disintegration of the tether into one or more fragments, the gastrointestinal device is releasable from the anchors; and   (b) a gastrointestinal device comprising a conformable sleeve having a proximal end and a distal end configured to carry fluid from the proximal end to the distal end, the gastrointestinal device further comprising a flange positioned at the proximal end of the sleeve, the flange having a plurality of apertures circumscribing the sleeve.   
     
     
         86 . The kit of  claim 85 , wherein the anchoring system is the anchoring system of any one of  claims 38 - 67 . 
     
     
         87 . The kit of  claim 85  or  86 , wherein the gastrointestinal device is the gastrointestinal device of any one of  claims 68 - 81 . 
     
     
         88 . A method of anchoring a gastrointestinal device in a gastrointestinal tract of a patient, the method comprising attaching a flange of a gastrointestinal device to a proximally oriented luminal surface proximal to the patient's pyloric orifice, wherein the flange comprises a plurality of apertures through which a plurality of anchors are configured to pass, the plurality of anchors releasably connected by a disintegrable tether, wherein the gastrointestinal device is held in place by the disintegrable anchors when the tether is intact, whereupon disintegration of the tether, the gastrointestinal device is releasable from the anchors. 
     
     
         89 . The method of  claim 88 , wherein the attaching of the flange of the gastrointestinal device comprises applying a distal force to the anchor assembly to puncture the proximally oriented luminal surface. 
     
     
         90 . The method of  claim 89 , wherein the attachment procedure is performed endoscopically. 
     
     
         91 . The method of any one of  claims 88 - 90 , wherein the anchors are the anchors of any one of  claims 10 - 27 . 
     
     
         92 . The method of any one of  claims 88 - 90 , wherein the anchors are the anchors of any one of  claims 43 - 57 . 
     
     
         93 . The method of any one of  claims 55 - 58 , wherein the gastrointestinal device is the device of any one of  claims 68 - 81 . 
     
     
         94 . A method of replacing a gastrointestinal device installed within the gastrointestinal tract of a subject, comprising:
 a) attaching a flange of a first gastrointestinal device to a proximally oriented luminal surface proximal to the patient's pyloric orifice, wherein the flange comprises a plurality of apertures through which a plurality of anchors are configured to pass, the plurality of anchors releasably connected by a first disintegrable tether, wherein the first gastrointestinal device is held in place by the anchors when the first tether is intact;   b) allowing the first tether to disintegrate after a clinically relevant period of time, whereupon disintegration of the first tether, the first gastrointestinal device is releasable from the anchors;   c) removing the first gastrointestinal device, leaving the anchors installed in the proximally oriented luminal surface proximal to the patient's pyloric orifice; and   d) attaching a flange of a second gastrointestinal device to the installed anchors, wherein the flange comprises a plurality of apertures through which the anchors are configured to pass, wherein the flange of the second gastrointestinal device is connected to the anchors with a second disintegrable tether.   
     
     
         95 . The method of  claim 94 , wherein the first gastrointestinal device is the gastrointestinal device of any one of  claims 68 - 81 . 
     
     
         96 . The method of  claim 94 , wherein the second gastrointestinal device is the gastrointestinal device of any one of  claims 68 - 81 . 
     
     
         97 . The method of any one of  claims 94 - 96 , wherein the anchors are the anchors of any one of  claims 43 - 57 . 
     
     
         98 . The method of any one of  claims 94 - 97 , wherein the disintegrable tether is the disintegrable tether of any one of  claim 39 - 42  or  58 - 67 . 
     
     
         99 . The method of any one of  claims 94 - 98 , wherein the removal of the first gastrointestinal device is performed endoscopically. 
     
     
         100 . The method of any one of  claims 94 - 98 , wherein the attaching of the second gastrointestinal device is performed endoscopically. 
     
     
         101 . A method of treating a metabolic disorder, the method comprising anchoring a gastrointestinal device using the anchoring system of any one of  claims 1 - 67 . 
     
     
         102 . A method of treating a metabolic disorder, the method comprising anchoring the gastrointestinal device of any one of  claims 68 - 81 . 
     
     
         103 . The method of  claim 101  or  102 , wherein the metabolic disorder is type 2 diabetes. 
     
     
         104 . The method of  claim 101  or  102 , wherein the metabolic disorder is non-alcoholic steatohepatitis (NASH). 
     
     
         105 . The method of  claim 101  or  102 , wherein the metabolic disorder is non-alcoholic fatty liver disease (NAFLD). 
     
     
         106 . The method of  claim 101  or  102 , wherein the metabolic disorder is obesity.

Join the waitlist — get patent alerts

Track US2020163785A1 — get alerts on status changes and closely related new filings.

We store only your email — no account needed. See our privacy policy.